Events

Recall of Tibial Alignment Guide

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Zimmer CAS.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    71202
  • Event Risk Class
    Class 2
  • Event Number
    Z-1701-2015
  • Event Initiated Date
    2015-04-19
  • Event Date Posted
    2015-06-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-05-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=137123
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Orthopedic stereotaxic instrument - Product Code OLO
  • Reason
    Zimmer cas has determined that the potential exists for the spikes on the iassist tibial alignment guide to bend or break during insertion or extraction from the tibia during use.
  • Action
    Zimmer distributed notices via certified mail on May 14, 2015. Zimmer is removing affected Tibial Alignment Guide iAssist Knee System product from distribution in a two-phased process. Based upon complaint investigation, Zimmer CAS has determined that the potential exists for the spikes on the iASSIST Tibial Alignment Guide to bend or break during insertion or extraction from the tibia during use. Customerswere asked to review the notifictaion, follow the iASSIST Surgical Knee Technique provided, further distribute the notice for any distributed product, inspect devices in use before and after procedures, report any adverse events, and complete the certificate of acknowledgment and return it to CorporateQuality.PostMarket@zimmer.com. Customers with questions concerning this notice, please contact Customer Service at the following address/phone number. Customer Service / Zimmer CAS 75 Queen Street, Suite 3300 Montreal, Quebec, Canada H3C 2N6 Email : cas-support@zimmercas.com, Telephone : 1-514-395-8883, toll free for North America 1-866-336-7846, Fax : 1-866-978-3801. For questions regarding this recall 574-372-4487.

Device

Tibial Alignment Guide
  • Model / Serial
    Item Number: 20-8011-013-00; Lot Numbers: 120265; 110623; 120659; 120794;120659-1; 130134; 120793; 130135
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including AL, AZ, CA, CA, CO, FL, IN, MI, NJ, NY, OH, OR, PA, TX, VA, and WI.
  • Product Description
    Tibial Alignment Guide; Orthopedic Stereotaxic Instrument;
  • Manufacturer
    Zimmer CAS

Manufacturer

Zimmer CAS
  • Manufacturer Address
    Zimmer CAS, 75 Queen St #3300, Montreal Canada
  • Manufacturer Parent Company (2017)
    Zimmer Biomet Holdings
  • Manufacturer comment
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source
    USFDA